ZOLPIDEM TARTRATE 10MG FILM-COATED TABLETS

Transcript

WHAT IS IN THIS LEAFLET:
1. What Zolpidem is and what it is used
for
2. What you need to know before you
take Zolpidem
3. How to take Zolpidem
4. Possible side effects
5. How to store Zolpidem
6. Contents of the pack and other
information

(Main)

Pharma code 574

1

WHAT ZOLPIDEM IS AND WHAT IT
IS USED FOR

Zolpidem belongs to a group of
medicines called hypnotics. These are
medicines which help you sleep.
Zolpidem is used for the short-term
treatment of severe sleeping difficulties,
which are causing you extreme distress.

2

WHAT YOU NEED TO KNOW
BEFORE YOU TAKE ZOLPIDEM

Always take Zolpidem exactly as your
doctor or pharmacist has told you. Check
with your doctor or pharmacist if you are
not sure.
Treatment with Zolpidem should be as
short as possible. The treatment usually
lasts from a few days to two weeks, up to
a maximum of four weeks. In certain
cases, treatment may last longer than
four weeks, but only if your doctor thinks
this is necessary.

01 August 2014

01 August 2014

HOW TO TAKE ZOLPIDEM

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Version:

Version:

Do NOT take Zolpidem:
• If you are allergic to zolpidem tartrate
or any of the other ingredients of this
medicine (listed in section 6).
• If you have myasthenia gravis (a
muscle disease where the muscles
become weak and tire easily)
• If you have severe breathing
difficulties, including difficulty in
breathing when asleep (sleep apnoea)
• If you have severe liver problems. In
patients with severe liver problems,
encephalopathy (a brain disorder) may
develop
• If you suffer from the rare hereditary
problems of galactose intolerance,
Lapp lactase deficiency or
glucose-galactose malabsorption
• If you are under the age of eighteen.
Warnings and precautions
Talk to your doctor or pharmacist before
taking Zolpidem
• If you are older people or frail. Due to
the muscle relaxing effect of
Zolpidem, there is a danger of falls,
particularly for the older people when
getting up at night.
• If you have a history of alcohol or drug
related problems
• If you have psychiatric problems or
mental illness including depression or
anxiety (as thoughts of suicide may
occur)
• If you have breathing difficulties
(hypnotics can mask the symptoms of
breathing difficulties such as anxiety
or agitation)
• If you have kidney problems
• If you have liver problems.
Important safety messages about
Zolpidem:
• Zolpidem may become less effective
after repeated use for a few weeks
(see section 3, How to take Zolpidem)
• Taking Zolpidem may lead to
dependence. This may be physical
dependence, where the body becomes
used to the presence of the medicine
and stopping treatment causes
withdrawal symptoms (see section 3,
If you stop taking Zolpidem), and/or
mental dependence, where you
develop a craving for the medicine.
Longer treatment periods and higher
doses, or a history of drug or alcohol
abuse, psychiatric problems or mental
illness increase the risk of dependence
occurring. To stop this from happening
your course of treatment should be as
short as possible, at as low a dose as

231-30-85166-W LEA ZOLPIDEM A/S FC TAB 28 TUK

Read all of this leaflet carefully before
you start taking this medicine because it
contains important information for you.
• Keep this leaflet. You may need to read
it again.
• If you have any further questions, ask
your doctor or pharmacist.
• This medicine has been prescribed for
you only. Do not pass it on to others. It
may harm them, even if their signs of
illness are the same as yours.
• If you get any side effects, talk to your
doctor or pharmacist. This includes
any possible side effects not listed in
this leaflet.

Top of page cut-off to middle of registration mark: 44 mm.

231-30-85166-W LEA ZOLPIDEM A/S FC TAB 28 TUK

PACKAGE LEAFLET: INFORMATION
FOR THE USER

possible and, at the end of the
treatment period, the dose should be
reduced gradually
• Behavioural effects (‘paradoxical
reactions’) may occur while taking
Zolpidem (see section 4, Possible Side
Effects)
• Zolpidem may cause amnesia (loss of
memory). This can occur several hours
after taking your medicine. To reduce
the risk, you should make sure that
you are able to have an uninterrupted
sleep of 7-8 hours.
Other medicines and Zolpidem
Tell your doctor or pharmacist if you are
taking or have recently taken or might
take any other medicines.
• rifampicin (used to treat severe
infections), as the dosage may need to
be adjusted
• muscle relaxants (e.g. baclofen), as
their muscle relaxing effect may be
increased
• medicines which may increase the
effect of Zolpidem, such as:
• antidepressants (e.g. amitriptyline,
phenelzine, fluoxetine)
• tranquillisers (e.g. chlorpromazine)
or other hypnotics (e.g. nitrazepam)
• sedatives (e.g. diazepam)
• narcotic painkillers (e.g. codeine,
morphine), as in combination with
Zolpidem euphoria (an increased
sensation of wellbeing) may be
enhanced which can lead to an
increased risk of dependence
• anti-epileptics (e.g. carbamazepine)
• sedative antihistamines (e.g.
alimemazine).
Tell the hospital doctor or your dentist
you are taking Zolpidem if you are going
to have an operation or dental treatment
requiring an anaesthetic.
Please tell your doctor or pharmacist if
you are taking or have recently taken any
other medicines, including medicines
obtained without a prescription.
Important information about some of the
ingredients of Zolpidem
• Patients who are intolerant to lactose
should note that Zolpidem tablets
contain a small amount of lactose. If
your doctor has told you that you have
an intolerance to some sugars, contact
your doctor before taking this medicine.
Zolpidem with food, drink and alcohol
• DO NOT drink alcohol whilst taking
these tablets, as the sedative effect of
Zolpidem may be increased.
Pregnancy, breast-feeding and fertility
• DO NOT take Zolpidem during the first
three months of pregnancy, or if you
are breast-feeding.
• If you are more than three months
pregnant, or planning to become
pregnant, ask your doctor or pharmacist
for advice before taking this medicine.
Driving and using machines
• Zolpidem may affect your concentraion
or muscle function.
The medicine can affect your ability to
drive as it may make you sleepy or dizzy.
• Do not drive while taking this medicine
until you know how it affects you.
• It is an offence to drive if this medicine
affects your ability to drive.
However, you would not be committing
an offence if:
• The medicine has been prescribed to
treat a medical or dental problem and
• You have taken it according to the
instructions given by the prescriber or
in the information provided with the
medicine and
• It was not affecting your ability to drive
safely.
Talk to your doctor or pharmacist if you
are not sure whether it is safe for you to
drive while taking this medicine.

TEVA UK Ref:

TEVA UK Ref:

ZOLPIDEM TARTRATE 5 mg
AND 10 mg FILM-COATED
TABLETS

If you do not notice any improvement
after 7 to 14 days, or you should think
that your tablets are not working as well
as they should, contact your doctor.
The tablets should be swallowed
preferably with a drink of water
immediately before going to bed. Try to
make sure that you will be able to sleep
uninterrupted for 7 or more hours. The
usual dose is:
• Adults:
The maximum recommended dose is
one 10 mg tablet or two 5 mg tablets
a day.
DO NOT take more than 10 mg in one
day.
• Children or adolescents under the
age of 18 years:
Zolpidem should not be taken by
children or adolescents under the age
of 18 years.
• Elderly or frail patients, and
patients with liver problems:
A lower dose of one 5 mg tablet a day
is recommended. Your doctor may
increase this to one 10 mg tablet a day
depending on your response to
Zolpidem.
You may become tolerant to the effects
of Zolpidem after you have been taking
it for a few weeks. If you notice that the
tablets are not working as well as they
did when you first started taking them,
you should go and see your doctor as an
adjustment to your dose may be necessary.
DO NOT change the dose yourself.
If you take more Zolpidem than you
should
If you (or someone else) swallow a lot of
the tablets all together, or if you think a
child has swallowed any of the tablets,
contact your nearest hospital casualty
department or your doctor immediately.
An overdose is likely to cause symptoms
ranging from sleepiness to a light coma.
Please take this leaflet, any remaining
tablets and the container with you to the
hospital or doctor so that they know
which tablets were consumed.
If you forget to take Zolpidem
If you fall asleep without taking a dose
and wake up some hours later, do not
take the missed dose. Take your normal
dose the following night.
If you stop taking Zolpidem
DO NOT stop taking your tablets
suddenly as you may suffer from
withdrawal effects or “re-bound
insomnia”. This means the symptoms
that required you to take your tablets in
the first place may reappear for a short
time. When your doctor decides to stop
your tablets, the dose will be reduced
gradually over a period of time.
Withdrawal effects may consist of:
• headache, muscular pain, extreme
anxiety, feelings of tension
• restlessness, confusion, irritability
and sleeping difficulties.
In severe cases the following symptoms
may occur:
• a feeling of detachment from your
surroundings
• a feeling of things being unreal
• sounds seeming louder than usual
(can sometimes be painful with loud
noises)
• numbness and tingling in the fingers
and toes
• sensitivity to light, noise and physical
contact
• hallucinations
• fits.
If you have any further questions on the
use of this product, ask your doctor or
pharmacist.

4

POSSIBLE SIDE EFFECTS

Like all medicines, Zolpidem can cause
side effects, although not everybody
gets them.
If the following happens, stop taking the
tablets and tell your doctor immediately
or go to the casualty department at your
nearest hospital:
• an allergic reaction (swelling of the
lips, face or neck leading to severe
difficulty in breathing; skin rash or
hives).
This is a very serious but rare side
effect. You may need urgent medical
attention or hospitalisation.

If you experience any of the following
effects, you should contact your doctor
immediately to discuss whether you
should continue taking the tablets:
• depression
• restlessness, agitation or irritability,
aggressiveness or anger, nightmares,
hallucinations, increased sleeping
difficulties, sleep-walking, untrue beliefs
or any other change in behaviour
(‘paradoxical reactions’). These effects
are more likely to occur in the elderly.
The following effects occur mainly at the
start of treatment and usually disappear
after a few days.
Common: may affect up to 1 in 10 people
• drowsiness (during the following day)
• reduced alertness
• confusion
• numbed emotions
• headache
• amnesia (loss of memory)
• dizziness
• vertigo
• stomach upsets (diarrhoea, nausea,
vomiting)
• skin rashes
• problems with sight (double vision).
Uncommon: may affect up to 1 in 100
people
• muscle weakness
• fatigue
• loss of co-ordination.
Rare: may affect up to 1 in 1,000 people
• decreased sex drive
• paradoxical reactions (see above for
details).
Reporting of side effects
If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet. You can also report side effects
directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help
provide more information on the safety of
this medicine.

5

HOW TO STORE ZOLPIDEM

Keep this medicine out of the sight and
reach of children.
Store in the original package. Do not
transfer the tablets to another container.
Do not use this medicine after the expiry
date which is stated on the outer
packaging after EXP. The expiry date refers
to the last day of that month.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines
you no longer use. These measures will
help protect the environment.

6

CONTENTS OF THE PACK AND
OTHER INFORMATION

What Zolpidem tablets contain:
• The active ingredient is zolpidem tartrate
• The other ingredients are lactose
monohydrate, microcrystalline
cellulose (E460), Type A sodium starch
glycolate, magnesium stearate (E572)
and hypromellose (E464). The coating
contains hypromellose (E464), titanium
dioxide (E171) and macrogol 400.
What Zolpidem tablets look like and
contents of the pack:
• The 5 mg tablets are white, oval,
biconvex, film-coated tablets. They are
embossed with ‘ZIM’ on one side and
‘5’ on the other side.
• The 10 mg tablets are white, oval,
biconvex, film-coated tablets, scored on
both sides. They are embossed with
‘ZIM’ and ‘10’ on one side.
• The product is available in pack sizes of
4, 5, 10, 14, 15, 20, 28, 30, 50, 100, and
500 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
The Marketing Authorisation holder and
company responsible for manufacture is
TEVA UK Limited, Eastbourne, BN22 9AG.
This leaflet was last revised: August 2014.
PL 00289/0426-0427

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.